Model #53110 Disposable Anoscope
FDA 510(k) K810227 · Welch Allyn, Inc.
510(k) numberK810227
Submission
- Device name
- Model #53110 Disposable Anoscope
- Applicant
- Welch Allyn, Inc.
Mchenry, IL, US - Received
- January 27, 1981
- Decision date
- February 19, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FER – Anoscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures within the anus and rectum.
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| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | Obp Corporation | 07/27/2012SE |
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Questions and answers
When was Model #53110 Disposable Anoscope cleared by the FDA?
Model #53110 Disposable Anoscope (K810227) received a 510(k) decision of Substantially Equivalent on February 19, 1981, 23 days after the submission was received.
What is the product code of K810227?
The FDA product code is FER – Anoscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.